Belgium Job Openings
UCB
Stability SME Senior Scientist
Braine-l'Alleud
FULL TIME
October 28, 2024
To strengthen our Analytical Processes & Operations - Stability Co E and Reporting team, we are looking for a talented individual to fill the position of Stability SME Senior Scientist, based in Braine-l’Alleud, Belgium.
About the Role
As a Stability SME Senior Scientist, you will oversee the stability of NCE and NBE. Participate to the management of regulatory aspect linked to the stability activities. You will provide expertise in stability processes, regulations, and product knowledge, ensuring effective communication with various departments and regulatory bodies.
Who You Will Work With
- Communication with UCB laboratories and subcontractors.
- Interaction with project managers.
- Collaboration with QA (Quality Assurance) and RA (Regulatory Affairs) teams.
What You Will Do
- Provide and develop knowledge and expertise for stability of NBE and NCE on UCB product process and regulation.
- Establish and participate to an efficient interface with QC and development laboratories, Co E Analytical, QA CLO and CMO and Global Regulatory affairs.
- Review and approve stability protocol.
- Create, review and approve stability report.
- Act as key user / expert LIMS stability.
- Contribute to the preparation and follow-up of the audits.
- Manage global improvements projects.
- Ensure follow up of deviations and appropriate root cause analysis.
- Ensure follow up of preventives and correctives actions.
- Participate to implementation of safe working environment to meet site safety objectives.
Interested? For this role, we are looking for the following qualifications, experience, and skills:
- Master’s Degree in a Science, Pharmacy or Chemistry.
- 5 years of experience in pharmaceutical industry.
- Strong NCE and NBE Analytical expertise is a must.
- Experience in both the R&D and commercial areas of the pharmaceutical industry required.
- Must have experience in a GMP regulated laboratory.
- Experience with FDA, European and Japanese investigators during on-site inspections, and experience interacting with Regulatory review staff on submission issues.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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